Thrives in a fastpaced environment with many concurrent tasks.
Support onsite and offsite activities such as: FATs SATs IOQ and PQ Executions and System Walkdowns.
Hands on experience in planning / directing C&Q activities of process equipment’s qualification.
Should have hands on experience in validation deliverables like URS design review P&IDs FAT SAT IQ OQ PQs protocols and reports generation & execution etc.
Should have good communication and collaboration skills enabling interaction with many stakeholders from different functions and cultures. Bachelor’s or master’s degree in a relevant science engineering or pharmaceutical field.
10 years experience performing commissioning and / or qualification activities in an FDA regulated industry.
Have hands on experience in validation deliverables like URS design review P&IDs FAT SAT IQ OQ PQs protocols and reports generation & execution etc.
Should have knowledge with recent edition of ISPE C&Q and GAMP and regulatory guidelines USFDA EU GMP Annexure 11 & 21 CFR 11 and ICH guidelines.
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